Catalog Number

S201 L Pro

Brand Name

SURGmatic S201 L Pro

Version/Model Number

1.013.7540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K140308

Product Code

EBW

Product Code Name

Controller, foot, handpiece and cord

Public Device Record Key

6793a9e7-d58f-4168-b233-ef81ceb915ae

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

January 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-